Senior Manager, Regulatory A&P — Remote & Global Impact

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 151,000 - 246,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager to join the Regulatory Affairs Advertising and Promotion team.

The role requires applying clinical development knowledge with promotion regulations to develop compliant product messages for BLAs/MAAs, advising commercial teams, and guiding cross-functional stakeholders. Responsibilities include managing US/global regulatory activities, liaising with FDA OPDP, reviewing materials, and driving process improvements to standardize policies

Qualifications

• Minimum 3–4 years within regulatory affairs, preferably in advertising and promotion.
• Bachelor’s degree in Life Sciences; advanced degree preferred; regulatory experience offset education.
• Knowledge of regulations, guidelines, and precedents for pharmaceutical product development and marketing.
• Experience with FDA OPDP/APLB or related interactions is preferred.

Responsibilities

• Manage US and Global regulatory activities for advertising and promotion of products.
• Advise on product messages and materials across functional areas.
• Provide regulatory guidance to Commercial teams and Medical Affairs on conferences and speaker programs.
• Review materials and communications to support goals and compliance with laws and guidance.
• Collaborate with Marketing, Medical Affairs, and Legal.
• Establish relationships with regulatory advertising and promotion professionals at partner companies.
• Interact with FDA OPDP for assigned products and manage advisory submissions.
• Ensure submissions to FDA on Form 2253 are compliant.
• Monitor evolving regulatory requirements and advise product teams accordingly.
• Provide input on process improvements for promotional review and standardization.

Skills

Regulatory strategy

FDA interaction

Cross-functional leadership

Regulatory guidance

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred (Masters, PharmD, PhD, MD or DO)

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager to join the Regulatory Affairs Advertising and Promotion team.

The role requires applying clinical development knowledge with promotion regulations to develop compliant product messages for BLAs/MAAs, advising commercial teams, and guiding cross-functional stakeholders. Responsibilities include managing US/global regulatory activities, liaising with FDA OPDP, reviewing materials, and driving process improvements to standardize policies